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Recruiting NCT07635095

A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants

Phase I Interventional Healthy Adult Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autoinjector, Vial and syringe.
Who it may be relevant to
Registry conditions: Healthy Adult Participants. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Randomized, Open-Label, Parallel-Group Trial Comparing the Pharmacokinetics of Navenibart Administered by Vial/Syringe Versus Autoinjector in Healthy Adult Volunteers

Overview

The goal of this clinical trial is to compare two different presentations (vial and syringe versus autoinjector) of navenibart in healthy adult volunteers. The main questions it aims to answer are: * Do these presentations lead to similar drug concentrations in the blood? * Do these presentations lead to similar safety and tolerability? Researchers will compare the drug concentrations and safety profile of each group to determine if they are similar. Participants will: * Receive one dose of navenibart with either the vial and syringe or the autoinjector. * Stay in the clinic beginning one day prior to dosing through 2 days after dosing. * Return to the clinic for approximately 9 additional non-residential visits. * Complete medical and other testing, including blood draws.

Interventions

  • Combination product Autoinjector
    Navenibart administered subcutaneously via autoinjector
  • Drug Vial and syringe
    Navenibart administered subcutaneously via vial and syringe

Primary outcome measures

  • Maximum concentration (Cmax) following a single dose of subcutaneous navenibart [Time frame: Up to 84 days post dose]
  • Area under the concentration versus time curve from time 0 to 84 days (AUC0-84d) following a single dose of subcutaneous navenibart [Time frame: Up to 84 days post dose]
Secondary outcome measures (6)
  • Time to reach maximum plasma concentration (Tmax) following a single dose of subcutaneous navenibart [Time frame: Up to 140 days post dose]
  • Apparent clearance (CL/F) following a single dose of subcutaneous navenibart [Time frame: Up to 140 days post dose]
  • Apparent volume of distribution during the terminal phase (Vz/F) following a single subcutaneous dose of navenibart [Time frame: Up to 140 days post dose]
  • Terminal half-life (t1/2) following a single subcutaneous dose of navenibart [Time frame: Up to 140 days post dose]
  • Incidence of treatment-emergent adverse events (TEAEs), including severity and relationship to navenibart following a single subcutaneous dose of navenibart [Time frame: Up to 168 days post dose]
  • Incidence and magnitude of treatment-emergent anti-drug antibodies (ADA) [Time frame: Up to 140 days post dose]

Eligibility criteria

Inclusion criteria

  • Males and females 18 to 55 years of age
  • In good health, as determined by the Investigator
  • Written informed consent, including confirmation of willingness to comply with all trial procedures
  • Body weight between 50 and 100 kg, and body mass index (BMI) between 18 and 30 kg/m\^2
  • Has not previously received navenibart
  • Not pregnant or breastfeeding and agreement to comply with requirements for pregnancy and breastfeeding, contraception use, and egg donation for the specified periods.

Exclusion criteria

  • Prior or ongoing medical history, or results of a medical assessment, that the Investigator feels could result in a risk to the safety of the participant or the quality of data from the trial.
  • Key laboratory results outside of defined ranges
  • History or positive test results for tobacco, nicotine products, alcohol, marijuana (cannabis), or drugs of abuse
  • Receipt of other prohibited medications, biologic medications, or investigational products within defined windows prior to dosing
  • History of severe allergic reactions with an unknown cause
  • Donation of blood (at least 500 mL), or any amount of platelets or plasma within defined windows prior to dosing.
  • Known hypersensitivity to any component of navenibart
  • Any condition that the Investigator feels may affect the ability to provide written informed consent or demonstrates unwillingness or inability to comply with trial procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 3 centers
  • Fortrea Clinical Trials — Daytona Beach
  • Fortrea Clinical Trials — Dallas
  • Fortrea Clinical Trials — Madison

Identifiers

NCT: NCT07635095 · STAR-0215-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗